Conference Call to be held Wednesday, November
10, 2021 at 5:00 pm (EST)
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB)
(“Navidea” or the “Company”), a company focused on the development
of precision immunodiagnostic agents and immunotherapeutics, today
announced its financial results for the third quarter and
year-to-date for the period ended September 30, 2021.
Alexander L. Cappello, Chair of Navidea’s Board of Directors,
said, “During this time of transition in our leadership, we remain
focused on our mission of developing precision immunodiagnostic
agents and immunotherapeutics to enhance patient care. We are
confident that our strong management team, supported by our
experienced and active Board of Directors, can execute on our
business plan and fulfill the vision we have for Navidea.”
Third Quarter 2021 Highlights and Subsequent Events
- Submitted draft Clinical Study Report to the U.S. Food and Drug
Administration (“FDA”) for the Company’s completed NAV3-31 Phase 2b
study in Rheumatoid Arthritis (“RA”) as part of the briefing
package for an End-of-Phase 2 Type B meeting.
- Held an End-of-Phase 2 Type B meeting with the FDA to discuss
the Company’s ongoing program in RA and advancement to the pivotal
Phase 3 trial September 1, 2021 via conference call.
- Opened a third site for enrollment in the Company’s NAV3-32
Phase 2b trial comparing Tc99m tilmanocept imaging to
histopathology of joints of patients with active RA. Enrollment is
ongoing and biopsy specimens are in the process of analysis.
- Nearly completed enrollment in the Company’s NAV3-35 Phase 2b
study, “Development of a Normative Database for Rheumatoid
Arthritis (RA) Imaging with Tc99m Tilmanocept.” Arm 1 is 4 subjects
from completion and Arm 2 is fully enrolled.
- Completed enrollment and imaging data analysis in the
investigator-initiated Phase 2 trial being run at the Massachusetts
General Hospital evaluating Tc99m tilmanocept uptake in
atherosclerotic plaques of HIV-infected individuals.
- Converted the provisional patent application “Synthesis of
Uniformly Defined Molecular Weight Mannosylated Dextrans and
Derivatives Thereof” to an A1 application on July 9, 2021.
- Appointed Alexander L. Cappello and John K. Scott, Jr. to the
Board of Directors. Mr. Scott is the Company’s largest shareholder
and Mr. Cappello brings over 30 years of banking and public board
experience to the Company.
- Appointed Thomas F. Farb and Agnieszka Winkler to the Board of
Directors. Mr. Farb has over three decades of experience as an
investor in and senior executive of numerous life science and
information technology companies both in the U.S. and
internationally, and Ms. Winkler has extensive professional and
board experience with start-up, mid-cap and Fortune 500
companies.
- Appointed Michel Mikhail, Ph.D. as Chief Regulatory Officer of
Navidea. Dr. Mikhail brings more than 30 years of experience in the
pharmaceutical industry and a track record of achievement in
research and development (“R&D”) and international regulatory
affairs at large multinational research-based pharmaceutical
companies.
- Jed A. Latkin resigned as Chief Executive Officer, Chief
Financial Officer and Chief Operating Officer of the Company and as
a member of the Company’s Board of Directors. The Company’s Board
of Directors has established an Executive Leadership Committee to
lead the Company on an interim basis while its next CEO is
identified. The Executive Leadership Committee includes Michael
Rosol, Ph.D., the Company’s Senior Vice President and Chief Medical
Officer; Erika Eves, the Company’s Vice President of Finance and
Administration; and Jeffrey Smith, the Company’s Vice President of
Operations. The Executive Leadership Committee will work with a
newly established Board Oversight Committee, consisting of
independent directors Alexander Cappello, Thomas Farb and John K.
Scott, Jr.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said,
“The clinical research team continues to work diligently to advance
the technology in key disease areas, with an emphasis on our RA
program. We have had a constructive dialogue with the FDA over the
results of the completed NAV3-31 Phase 2b trial as well as our
proposed plan for the NAV3-33 Phase 3 study, and we continue to
prepare for initiation of this trial. We also have active
enrollment in the NAV3-32 Phase 2b trial comparing tilmanocept
imaging to synovial tissue biopsy samples of RA patients, and have
near full enrollment in the NAV3-35 normative database study.
Concurrent with all of this, we continue to make exciting progress
in our therapeutics pipeline, and we expect to keep advancing these
towards the clinic.”
Financial Results
- Total net revenues for the third quarter of 2021 were $96,000,
compared to $268,000 for the same period in 2020. Total net
revenues for the first nine months of 2021 were $481,000, compared
to $695,000 for the same period in 2020. The decrease was primarily
due to decreased grant revenue related to Small Business Innovation
Research grants from the National Institutes of Health supporting
Manocept™ development, offset by receipt of reimbursement from
Cardinal Health 414, LLC of certain R&D costs and the partial
recovery of debts previously written off in 2015.
- R&D expenses for the third quarter of 2021 were $1.0
million, compared to $1.4 million in the same period in 2020.
R&D expenses for the first nine months of 2021 were $3.8
million, compared to $3.7 million in the same period in 2020. The
net increase during the year to date was primarily due to net
increases in drug project expenses, including increased Manocept
therapeutic and Tc99m tilmanocept development costs, offset by
decreased Manocept diagnostic development costs. The net increase
in research and development expenses also included increased
regulatory consulting and general office expenses offset by
decreased employee compensation including incentive-based
awards.
- Selling, general and administrative (“SG&A”) expenses for
the third quarter of 2021 were $1.5 million, compared to $1.8
million in the same period in 2020. SG&A expenses for the first
nine months of 2021 were $5.1 million, compared to $4.9 million in
the same period in 2020. The net increase during the year to date
was primarily due to increased consulting services related to
preparation for European distribution of Tc99m tilmanocept,
increased employee compensation including incentive-based awards,
increased insurance cost, increased director fees related to
additional board members, increased travel costs, increased
European license fees, increased general office expenses, and a
loss on the third quarter 2021 abandonment of certain intellectual
property, offset by decreased legal and professional services,
decreased investor relations costs, decreased facilities costs and
decreased franchise taxes.
- Navidea’s net loss attributable to common stockholders for the
third quarter of 2021 was $2.4 million, or $0.08 per share,
compared to $3.3 million, or $0.13 per share, for the same period
in 2020. Navidea’s net loss attributable to common stockholders for
the first nine months of 2021 was $8.1 million, or $0.28 per share,
compared to $8.4 million, or $0.37 per share, for the same period
in 2020.
- Navidea ended the third quarter of 2021 with $7.2 million in
cash and cash equivalents.
Conference Call Details
Investors and the public are invited to dial into the earnings
call through the information listed below, or participate via the
audio webcast on the company website. As noted in the Company’s
press release dated November 3, 2021, questions will not be taken
during the conference call. Previously-submitted questions will be
read aloud and answered during the Q&A portion of the
conference call, and we may also respond to questions on an
individual basis or by posting answers on our website after the
call.
Event: Third Quarter 2021 Earnings Conference
Call and Business Update Date: Wednesday, November 10, 2021 Time:
5:00 p.m. (EST) U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899 Conference ID: 13724382
Webcast Link: https://webcast-eqs.com/navidbioph20211110/en
A live audio webcast of the conference call will be available on
the investor relations page of Navidea’s corporate website at
www.navidea.com. In addition, the recorded conference call can be
replayed and will be available for 90 days following the call on
Navidea’s website.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a
biopharmaceutical company focused on the development of precision
immunodiagnostic agents and immunotherapeutics. Navidea is
developing multiple precision-targeted products based on its
Manocept™ platform to enhance patient care by identifying the sites
and pathways of disease and enable better diagnostic accuracy,
clinical decision-making, and targeted treatment. Navidea’s
Manocept platform is predicated on the ability to specifically
target the CD206 mannose receptor expressed on activated
macrophages. The Manocept platform serves as the molecular backbone
of Tc99m tilmanocept, the first product developed and
commercialized by Navidea based on the platform. Navidea’s strategy
is to deliver superior growth and shareholder return by bringing to
market novel products and advancing the Company’s pipeline through
global partnering and commercialization efforts. For more
information, please visit www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. We have based these forward-looking statements largely on
our current expectations and projections about future events and
financial trends affecting the financial condition of our business.
Forward-looking statements include our expectations regarding
pending litigation and other matters. These forward-looking
statements are subject to a number of risks, uncertainties and
assumptions, including, among other things: our history of
operating losses and uncertainty of future profitability; the final
outcome of any pending litigation; our ability to successfully
complete research and further development of our drug candidates;
the timing, cost and uncertainty of obtaining regulatory approvals
of our drug candidates; our ability to successfully commercialize
our drug candidates; dependence on royalties and grant revenue; our
ability to implement our growth strategy; anticipated trends in our
business; our limited product line and distribution channels;
advances in technologies and development of new competitive
products; our ability to comply with the NYSE American continued
listing standards; our ability to maintain effective internal
control over financial reporting; the impact of the current
coronavirus pandemic; and other risk factors detailed in our most
recent Annual Report on Form 10-K and other SEC filings. You are
urged to carefully review and consider the disclosures found in our
SEC filings, which are available at http://www.sec.gov or at
http://ir.navidea.com.
Investors are urged to consider statements that include the
words “will,” “may,” “could,” “should,” “plan,” “continue,”
“designed,” “goal,” “forecast,” “future,” “believe,” “intend,”
“expect,” “anticipate,” “estimate,” “project,” and similar
expressions, as well as the negatives of those words or other
comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any
forward-looking statements, any of which could turn out to be
incorrect. We undertake no obligation to update publicly or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise after the date of this
report. In light of these risks and uncertainties, the
forward-looking events and circumstances discussed in this report
may not occur and actual results could differ materially from those
anticipated or implied in the forward-looking statements.
NAVIDEA BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30,
December 31,
2021
2020
(unaudited)
Assets: Cash and cash equivalents
$
7,176,211
$
2,670,495
Other current assets
480,749
3,857,833
Non-current assets
1,302,586
1,229,690
Total assets
$
8,959,546
$
7,758,018
Liabilities and stockholders' equity: Current liabilities
$
4,096,516
$
4,715,105
Deferred revenue, non-current
700,000
700,000
Other liabilities
29,036
296,006
Total liabilities
4,825,552
5,711,111
Navidea stockholders' equity
3,402,695
1,315,604
Noncontrolling interest
731,299
731,303
Total stockholders' equity
4,133,994
2,046,907
Total liabilities and stockholders' equity
$
8,959,546
$
7,758,018
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
Three Months Ended
Nine Months Ended
September 30,
September 30,
September 30,
September 30,
2021
2020
2021
2020
(unaudited)
(unaudited)
(unaudited)
(unaudited)
Revenue
$
96,382
$
268,389
$
481,165
$
695,762
Cost of revenue
-
82
-
1,048
Gross profit
96,382
268,307
481,165
694,714
Operating expenses: Research and development
1,048,786
1,377,998
3,769,596
3,659,046
Selling, general and administrative
1,469,375
1,788,934
5,132,730
4,946,279
Total operating expenses
2,518,161
3,166,932
8,902,326
8,605,325
Loss from operations
(2,421,779
)
(2,898,625
)
(8,421,161
)
(7,910,611
)
Other income (expense): Interest income (expense), net
(2,814
)
(149
)
(4,423
)
12,822
Gain on extinguishment of debt
-
-
366,000
-
Other, net
2,800
(564
)
(3,141
)
(777
)
Loss before income taxes
(2,421,793
)
(2,899,338
)
(8,062,725
)
(7,898,566
)
Provision for income taxes
(16,043
)
-
(16,043
)
-
Net loss
(2,437,836
)
(2,899,338
)
(8,078,768
)
(7,898,566
)
Loss (income) attributable to noncontrolling interest
1
-
4
(1
)
Deemed dividend on Series C and Series D preferred stock beneficial
conversion feature
-
(405,555
)
-
(483,333
)
Net loss attributable to common stockholders
$
(2,437,835
)
$
(3,304,893
)
$
(8,078,764
)
$
(8,381,900
)
Loss attributable to common stockholders per common share
(basic and diluted)
$
(0.08
)
$
(0.13
)
$
(0.28
)
$
(0.37
)
Weighted average shares outstanding (basic and diluted)
30,122,549
25,843,732
29,067,784
22,946,201
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211110006238/en/
Investor Relations Contact Navidea Biopharmaceuticals,
Inc. Jeff Smith Vice President of Operations 614-822-2365
jsmith@navidea.com
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